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Recall Observatory FDA recall evidence

Device product

Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn

Z-1639-2017

January 09, 2017

Class II

Product summary

Firm
Resource Optimization & Innovation Llc
Event
Event 76255
Status
Terminated
Classification
Class II
Quantity
3,000 kits
Official record key
device-enforcement:Z-1639-2017

Official wording

Reason: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information: 034435B Exp Date 2018-6-21; 037051B Exp Date 2018-6-21; 037462B Exp Date 2018-07-29; 038293B Exp Date 2018-08-17; 038779B Exp Date 2018-09-21; 039465B Exp Date 2018-10-10; 040093B Exp Date 2018-11-09;

Distribution pattern: US Distribution to LA and TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breaking the sterile field